Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk (SWET/CHAT)

This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training (SWET) program.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: CHAT: Counseling Health As Treatment; Other: SWET: Supervised Weight loss and Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Center For Living

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body mass index (BMI) 28-40 kg/m2.
• Must have internet access.
• Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.

Exclusion Criteria:

• Subject unwilling/unable to utilize online platforms (e.g. ZOOM, REDCap, Pattern Health) for study activities.
• Current use of biologic agents other than those targeting tumor necrosis factor alpha.
• Current (within the last month) pharmacologic therapy with corticosteroids at doses greater than prednisone 5mg per day (or equivalent glucocorticoid doses).
• Participating in regular exercise within the past 3 months (According to 2018 US guidelines: Not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise).
• New medications within the last three months and stable doses for ≥ 1 month.
• Diagnosis of coronary artery disease.
• Diagnosis of type 2 diabetes mellitus.
• Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease.
• Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection.
• Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately.
• Significant weight change (gain or loss of > 10 pounds in 1 month) within the past 6 months.
• Unwillingness or inability to adhere to the diet structure of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Counseling Health As Treatment (CHAT); CHAT is a control arm designed to reflect traditional clinical counselling.	Other: CHAT: Counseling Health As Treatment; Control Arm over 16 weeks.
Experimental: Supervised Weight loss and Exercise Training (SWET); SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session.	Other: SWET: Supervised Weight loss and Exercise Training; Weight loss will occur via a dietitian-led intervention targeting weight loss over 16 weeks, with weekly weigh-ins and group support sessions. Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Syndrome Severity Z-score (MSSc)	The primary objective is to compare change in metabolic syndrome z-score (MSSc) between groups. The MSSc is a continuous weighted score of the five metabolic syndrome variables-fasting high-density lipoprotein cholesterol, triglycerides, glucose, waist circumference, and mean arterial blood pressure. A modified z-score was calculated for each participant using continuous differences between the Adult Treatment Panel (ATP) III guideline values and participant values with normalization to the cohort's standard deviations. To account for variations in ATP III criteria between men and women, the investigators used sex-specific MSSc equations. A lower MSSc indicates a better outcome.	Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire	Change in patient-reported outcomes using PROMIS Physical Function Questionnaire. The questionnaire was scored using "response pattern scoring" according to the PROMIS scoring manual in order to calculate the T-score for this outcome measure. The population mean T-score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average.	Baseline and 16 weeks
Disease Activity Score (DAS-28)	Change in disease activity measured using the DAS-28. DAS-28 is a composite measure including a self-reported overall health assessment on a 100 mm visual analog scale, the number of tender and swollen joints determined from a 28-joint examination, and C-reactive protein. Scores range from 0 [very well] to 10 [very poor].	Baseline and 16 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Nutrition; Diet; Cardiovascular Risk; RA Seropositive; RA Erosive
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Body Weight Changes; Arthritis; Arthritis, Rheumatoid; Weight Loss
• Other Study ID Numbers: Pro00104843; R21AR076663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No